Online – February 2026 – As global development of biologics, biosimilars, and advanced therapy medicinal products (ATMPs) accelerates, immunogenicity remains one of the most significant scientific and regulatory risks impacting clinical outcomes and market approval. Regulatory authorities, including the EMA and FDA, are placing increased emphasis on robust immunogenicity risk assessment, validated bioanalytical assays, and continuous monitoring of anti-drug antibodies (ADAs), following growing evidence of unexpected immune responses compromising safety, efficacy, and product comparability. In response to these challenges, Fleming announces the Immunogenicity of Biologics, Biopharmaceuticals & ATMPs Online Live Training Course, taking place on 28 & 29 April 2026, from 13:00–18:00 CEST.

Recent regulatory updates highlight persistent gaps in preclinical study design, assay sensitivity, and the interpretation of immunogenicity data across clinical phases. Industry experts continue to stress the need for integrated strategies covering ADA detection, confirmation, neutralization, and risk minimization across diverse product classes, including monoclonal antibodies, biosimilars, and ATMPs. This live training addresses these priorities through in-depth coverage of immunogenicity fundamentals, analytical assay development, ADA characterization and monitoring, and evolving EU versus FDA regulatory and quality expectations, supported by real-world case studies.

Delivered by senior experts in regulatory science and bioanalytical development, the course equips participants with practical tools to strengthen immunogenicity strategies, reduce late-stage development risk, and align with current regulatory expectations. Attendees gain immediately applicable insights to support safer, more efficient biologics and ATMP development programs.

Media & Registration Contact
Karthik Naik
E: [email protected]
T: +421 257 272 100
W: fleming.events